A Phase III Study of Pembrolizumab Immunotherapy plus Lenvatinib versus Docetaxel for Metastatic Non-Small Cell Lung Cancer that Continues to Grow Despite Chemotherapy and Immunotherapy

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Full Title

A Phase 3, multicenter, randomized, open-label trial to compare the efficacy and safety of pembrolizumab (MK-3475) in combination with lenvatinib (E7080/MK-7902) versus docetaxel in previously treated participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and immunotherapy (anti-PD-1/PD-L1 inhibitor)(LEAP-008)(WIRB)

Purpose

The purpose of this study is to compare three treatment combinations for people with metastatic non-small cell lung cancer (NSCLC) that has continued to grow despite prior treatment with chemotherapy and immunotherapy. Patients will be randomly assigned to one of three treatments, with most patients in the first two groups:

  • Pembrolizumab immunotherapy plus lenvatinib
  • Docetaxel chemotherapy
  • Lenvatinib alone

Pembrolizumab is already used to treat advanced NSCLC and is used in combination with lenvatinib for endometrial cancer. Lenvatinib for NSCLC is considered investigational. Docetaxel is a standard chemotherapy drug for NSCLC. Pembrolizumab and docetaxel are given intravenously (by vein) and lenvatinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic NSCLC that continues to grow despite prior treatment that included immunotherapy (a PD-1 or PD-L1 inhibitor) and chemotherapy that included a platinum-containing drug plus another drug.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Prior treatment with docetaxel or lenvatinib is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Matthew Hellmann at 646-888-4863.

Protocol

19-281

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators